Sequential Therapy Anti-obesitY Medication With Muscle Preservation for Weight Loss and MaintEnance: A PragmAtic Randomized CoNtrolled Trial (STAY-LEAN Trial)

What Was Tested

In this phase 4 trial, researchers set out to test Tirzepatide and Semaglutide for fat loss, obesity & body recomposition.

This is a prospective, pragmatic, 21 month, single-center, randomized, 2-phased, open-label, parallel-group trial comparing the use of enhanced lifestyle changes (ELC) in two different therapy: sequential vs continuation of AOM.

It had two arms (groups): Group 1 AOM (experimental) and Group 2 (experimental).

Comprehensive weight loss Program + Enhanced lifestyle changes + Group 1 AOM sequential therapy.

Comprehensive weight loss + Enhanced lifestyle changes + Group 2 Continuation of Therapy.

The registry classes the interventions as drug and other.

More on the Plan

In recognition of the biologic basis and seriousness of obesity, several professional health associations and organizations worldwide recognize obesity as a disease .

Obesity is often stigmatized and viewed as a personal choice or lack of willpower, rather than a chronic disease, complex disease that can result from a combination of genetic, environmental, and behavioral factors, including diet and physical activity levels.

Currently, estimates for these costs are $497 billion per year in direct health care costs, and $1.24 trillion in indirect costs due to lost productivity in 2016.

Of the approximately 70,000 adult employees and their spouses on the Health Plan, approximately 22,000 have obesity, defined by BMI ≥ 30 kg/m2, and more than 8,000 suffer severe obesity (BMI ≥ 35 kg/m2).

Who Took Part

The registry lists 150 actual participants took part.

It was open to people of any sex aged from 25 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Gender: men and women. Ethnicity: all ethnic groups. Age: ≥ 25, \< 65 years.

The full record lists 3 inclusion and 27 exclusion criteria; among the exclusions: patients with history of diabetes; currently or within the past 6 months receiving an anti-obesity medication, or any other medication used for the primary intent of weight loss; mental incapacity or language barrier.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Tirzepatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Tirzepatide group and the comparison group ran side by side rather than switching.

Everyone knew when Tirzepatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2025-03-01 with completion listed for 2027-04-28.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Weight change (time frame: month 9 to month 21).

It also tracked 1 secondary outcome, for example Change in body weight %.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Tirzepatide and Semaglutide in 150 people with fat loss, obesity & body recomposition.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page and the Semaglutide compound page, Fat loss, obesity & body recomposition research.